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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01236729
Other study ID # KL122009
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2009
Est. completion date December 31, 2015

Study information

Verified date October 2023
Source Coxa, Hospital for Joint Replacement
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Knee replacement is an effective treatment in late-stage osteoarthritis. It reduces pain and improves quality of life. There is, however, limited data concerning its results in older people and on its effect on how patients survive in regular activities of daily living (ADL), such as bathing and shopping. In this study, the results of knee replacement are evaluated from the point of view of disability in everyday activities and self-rated health. Moreover, association with ADL performance and clinical knee scores and severity of osteoarthritis are assessed.


Description:

This is a cross-sectional study with a 12 month follow-up for recruited patients. Most data are gathered by a postal questionnaire.


Recruitment information / eligibility

Status Completed
Enrollment 460
Est. completion date December 31, 2015
Est. primary completion date November 30, 2013
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria: - age 75 years or more at the time of operation - diagnosis of knee osteoarthritis - scheduled for or operated on with primary knee replacement Exclusion Criteria: - died during the follow-up - inflammatory arthritides

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Finland Coxa, Hospital for Joint Replacement Tampere

Sponsors (2)

Lead Sponsor Collaborator
Coxa, Hospital for Joint Replacement Tampere University

Country where clinical trial is conducted

Finland, 

References & Publications (2)

Limnell K, Jamsen E, Huhtala H, Jantti P, Puolakka T, Jylha M. Functional ability, mobility, and pain before and after knee replacement in patients aged 75 and older: a cross-sectional study. Aging Clin Exp Res. 2012 Dec;24(6):699-706. doi: 10.3275/8718. — View Citation

Vekama L, Puolakka T, Honkasalo M, Huhtala H, Moilanen T, Jamsen E. Functional gain following knee replacement in patients aged 75 and older: a prospective follow-up study. Aging Clin Exp Res. 2015 Dec;27(6):865-76. doi: 10.1007/s40520-015-0348-x. Epub 20 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Disability in activities of daily living Baseline (recruitment) and at 12 months
Secondary Overall self-rated health Baseline (recruitment) and at 12 months
Secondary Health-related quality of life (WOMAC) For patients recruited in 2011-2012. Baseline and 12 months postoperatively
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